1.Quality Evaluation of Gegen Qinlian Tablets Based on HPLC Multi-component Quantification Combined with Chemical Pattern Recognition and TOPSIS Analysis
Ping QIN ; Yingying LU ; Wenming ZHANG ; Zifang FENG ; Lihong GU ; Chenjie XIA ; Minmin HU ; Xiaowei CHEN ; Zhenhua BIAN ; Xiwan LU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):217-224
ObjectiveTo establish a high-performance liquid chromatography(HPLC) for the quantitative analysis of multiple components in Gegen Qinlian tablets, and to comprehensively evaluate the quality of samples from different manufacturers by integrating chemical pattern recognition and technique for order preference by similarity to ideal solution(TOPSIS), in order to provide a reference basis for quality evaluation and control of Gegen Qinlian tablets. MethodsHPLC was employed to determine the contents of 10 components in 28 batches of Gegen Qinlian tablets collected from 6 manufacturers, and taking the detection results as variables, SIMCA 14.1 and SPSS 26.0 were employed for cluster analysis(CA), principal component analysis(PCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA) to identify key components affecting the quality. Then, TOPSIS analysis was employed to rank the quality of Gegen Qinlian tablets from the 6 manufacturers and establish a comprehensive quality evaluation method. ResultsA quantitative method for Gegen Qinlian tablets was established. After methodological validation, the method was found to be stable and reliable, and could be used for the quantitative analysis of this preparation. The contents of 3′-hydroxy puerarin, puerarin, 3′-methoxy puerarin, daidzein, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, berberine hydrochloride, palmatine hydrochloride and baicalin in 28 batches of samples were 3.58-7.35, 24.88-42.32, 4.20-9.36, 4.33-7.60, 2.52-6.44, 0.93-4.10, 0.58-3.05, 10.68-22.92, 0.82-4.82, 11.73-60.16 mg·g-1, respectively. Among them, puerarin, berberine hydrochloride and baicalin all met the limit requirements for this preparation specified in the 2025 edition of the Pharmacopoeia of the People's Republic of China. CA and PCA clustered the 28 batches of samples into 5 categories, PCA extracted 2 principal components with a cumulative variance contribution rate of 90.588%, and OPLS-DA screened out 4 differential markers with variable importance in the projection(VIP) values>1.0, namely baicalin, 3′-hydroxy puerarin, coptisine hydrochloride and palmatine hydrochloride, which might be the main components affecting the quality of Gegen Qinlian tablets. TOPSIS analysis showed that the comprehensive score of each evaluation index(Ci) values of different manufacturers were different. Among them, the Ci of manufacturer B was ranked higher, indicating potentially superior quality, while the Ci of manufacturer A was ranked lower, suggesting potentially inferior quality. ConclusionThis study establishes a quantitative method for Gegen Qinlian tablets, and the content uniformity of the same manufacturer is good, while there are differences in the contents of active components among different manufacturers. Through the chemical pattern recognition analysis, it is found that the content differences of Gegen Qinlian tablets may be related to baicalin, 3′-hydroxy puerarin, coptisine hydrochloride and palmatine hydrochloride.
2.Pathogenesis of Diabetic Nephropathy and Traditional Chinese Medicine Intervention Based on Signaling Pathways: A Review
Yaohong LU ; Chenjie HUANG ; Wenqi YUAN ; Haidong ZHOU ; Gengxin LIU ; Gedi ZHANG ; Ziyou YAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):287-299
Diabetic nephropathy (DN) is one of the most common and severe microvascular complications of diabetes, with a complex pathogenesis involving immune inflammatory responses, oxidative stress, apoptosis, glomerulosclerosis, renal interstitial fibrosis, and other pathological processes. In recent years, numerous animal or cell model experiments have revealed that the transforming growth factor-β (TGF-β)/mothers against decapentaplegic homolog (Smad), phosphoinositide 3-kinase (PI3K)/ protein kinase B (Akt)/mammalian target of rapamycin (mTOR), mitogen-activated protein kinase (MAPK), AMP-activated protein kinase (AMPK), nuclear factor-κB (NF-κB), Janus kinase (JAK)/signal transducer and activator of transcription (STAT), neurogenic locus notch homolog protein (Notch), nuclear factor E2-related factor 2 (Nrf2), secretory glycoprotein (Wnt)/β-catenin, and other classical signaling pathways play important roles in the occurrence and development of DN. Traditional Chinese medicines, as natural drugs, possess characteristics such as multiple components, multiple targets, and few adverse reactions, demonstrating unique advantages in regulating the aforementioned signaling pathways and improving renal pathological changes. This review summarized recent research progress on the intervention of DN through the regulation of the aforementioned signaling pathways by single compounds and formulas of traditional Chinese medicine, focusing on their mechanisms of action in regulating immune inflammatory responses, inhibiting renal fibrosis, oxidative stress, improving metabolic disorders, and other aspects. The aim is to provide theoretical references for a deeper understanding of the modern pharmacological basis and clinical application of traditional Chinese medicine in the treatment of DN.
3.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
4.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
5.Study on HPLC fingerprint and multi-component determination of Ziziphus jujuba stir-fried with Coptis chinensis juice from Longsha Medical School
Ping QIN ; Yingying LU ; Wenming ZHANG ; Zifang FENG ; Lihong GU ; Chenjie XIA ; Minmin HU ; Xiaowei CHEN ; Tulin LU ; Yiting ZHANG ; Zhenhua BIAN
China Pharmacy 2026;37(15):1974-1978
OBJECTIVE To establish a high-performance liquid chromatography(HPLC) fingerprint and a multi-component content determination method for Ziziphus jujuba stir-fried with Coptis chinensis juice, a characteristic processed product of Longsha Medical School, and to provide a basis for the inheritance and clinical application of this distinctive variety. METHODS HPLC method was employed to establish the fingerprints of 12 batches of Z. jujuba stir-fried with C. chinensis juice. Similarity evaluation and common peak identification were subsequently carried out. Quantitative determination was performed on coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, 6"'-feruloylspinosin, and jujuboside A of samples. RESULTS The fingerprint similarities of all 12 batches of samples were higher than 0.960. A total of 17 common peaks were calibrated, among which 9 peaks were identified as coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, and 6"'-feruloylspinosin, respectively. The quantitative results showed that the mass fractions of coclaurine, magnoflorine, coptisine hydrochloride, epiberberine, jatrorrhizine hydrochloride, spinosin, berberine hydrochloride, palmatine hydrochloride, 6"'-feruloylspinosin, and jujuboside A in the 12 batches of samples were 0.044-0.091, 0.908-1.698, 0.325-0.549, 0.163-0.287, 0.103-0.172, 0.712-0.952, 1.185-1.843, 0.341-0.598, 0.228-0.405, and 0.050-0.091 mg/g, respectively. CONCLUSIONS The established HPLC fingerprint and multi-component determination method is stable and reliable, and can provide a basis for the quality standard formulation and clinical application of Z. jujuba stir-fried with C. chinensis juice.
6.Expert consensus on the application of nasal cavity filling substances in nasal surgery patients(2025, Shanghai).
Keqing ZHAO ; Shaoqing YU ; Hongquan WEI ; Chenjie YU ; Guangke WANG ; Shijie QIU ; Yanjun WANG ; Hongtao ZHEN ; Yucheng YANG ; Yurong GU ; Tao GUO ; Feng LIU ; Meiping LU ; Bin SUN ; Yanli YANG ; Yuzhu WAN ; Cuida MENG ; Yanan SUN ; Yi ZHAO ; Qun LI ; An LI ; Luo BA ; Linli TIAN ; Guodong YU ; Xin FENG ; Wen LIU ; Yongtuan LI ; Jian WU ; De HUAI ; Dongsheng GU ; Hanqiang LU ; Xinyi SHI ; Huiping YE ; Yan JIANG ; Weitian ZHANG ; Yu XU ; Zhenxiao HUANG ; Huabin LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):285-291
This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans
;
Nasal Cavity/surgery*
;
Nasal Surgical Procedures
;
China
;
Consensus
;
Sinusitis/surgery*
;
Dermal Fillers
7.Efficacy analysis of modified endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps complicated by allergic rhinitis
Xianmei WEI ; Qingzhao ZHANG ; Chenjie YU ; Xinyan CUI
Journal of Clinical Medicine in Practice 2025;29(14):52-55
Objective To observe the efficacy of modified endoscopic sinus surgery(ESS)in treatment of chronic rhinosinusitis with nasal polyps(CRSwNP)complicated by allergic rhinitis(AR).Methods Forty patients with CRSwNP and perennial AR who were scheduled for ESS were divided into study group and control group,with 20 cases in each group.The control group was treated with conventional ESS,while the study group underwent resection of a large part of the middle turbi-nate on the basis of ESS to enhance middle meatal drainage.The postoperative mucosal outcomes,complications,as well as the Visual Analog Scale(VAS),sino-nasal outcome test-20(SNOT-20),and nasal endoscopic Lund-Kennedy scores before surgery,at 3 months after surgery,and at 1 year af-ter surgery were compared between the two groups.Results In the control group,there were 3 cases of local adhesion between the displaced middle turbinate and the lateral nasal wall at 3 months after surgery,and 10 cases of middle turbinate edema at 1 year after surgery,including 4 cases with local polypoid changes in the middle turbinate and polypoid hyperplasia in the ethmoid sinus and frontal re-cess regions.No complications were observed in the study group,and the epithelialization of the surgical area was good.Moreover,the nasal congestion score,olfactory score,and Lund-Kennedy score at 1 year after surgery in the study group were lower than those in the control group,with statistically significant differences(P<0.05).Conclusion Modified ESS can significantly improve nasal con-gestion and olfactory symptoms in patients with CRSwNP complicated by perennial AR and effective-ly enhance their quality of life.
8.A preliminary study on the transverse changes during molar distalization with Clear Aligners
Chenjie PU ; Yanxiao ZHANG ; Shu LOU
Journal of Practical Stomatology 2025;41(6):793-797
Objective:The aim of this research was to study the transverse changes during molar distalization with clear aligner treatment,and to evaluate the predictability.Methods:This retrospective study included the following two parts:(1)20 patients treated with Invisalign system were selected.Their digital models were measured with OrthoCAD(Align Technology)and then com-pared with the initial ClinCheck arch width to verify the consistency between them;(2)34 patients whose maxillary molars were dis-talized,and 12 patients whose maxillary and mandibular molars were both distalized,were involved.The widths between canines,premolars and molars were recorded from Clincheck software at T0(initial),T1(Invisalign-predicted),and T2(pretreatment,from the refinement ClinCheck plan)and then compared.Results:The measured value of dental arch width of OrthoCAD and ClinCheck were consistent.After wearing the first stage appliance,the width between maxillary and mandibular teeth at T2 ranges from 1.63 to 3.45 mm.In the maxilla,the width at T1 differed from that at T2 and the predictability ranged from 80.43%to 82.29%,while the predictability ranged from 88.88%to 93.08%in the mandible.Conclusion:(1)The arches were expanded during molar distaliza-tion with clear aligners;(2)The predictability ranged from 80.43%to 93.08%.It can be considered that the actual width change is close to the target change.
9.A preliminary study on the transverse changes during molar distalization with Clear Aligners
Chenjie PU ; Yanxiao ZHANG ; Shu LOU
Journal of Practical Stomatology 2025;41(6):793-797
Objective:The aim of this research was to study the transverse changes during molar distalization with clear aligner treatment,and to evaluate the predictability.Methods:This retrospective study included the following two parts:(1)20 patients treated with Invisalign system were selected.Their digital models were measured with OrthoCAD(Align Technology)and then com-pared with the initial ClinCheck arch width to verify the consistency between them;(2)34 patients whose maxillary molars were dis-talized,and 12 patients whose maxillary and mandibular molars were both distalized,were involved.The widths between canines,premolars and molars were recorded from Clincheck software at T0(initial),T1(Invisalign-predicted),and T2(pretreatment,from the refinement ClinCheck plan)and then compared.Results:The measured value of dental arch width of OrthoCAD and ClinCheck were consistent.After wearing the first stage appliance,the width between maxillary and mandibular teeth at T2 ranges from 1.63 to 3.45 mm.In the maxilla,the width at T1 differed from that at T2 and the predictability ranged from 80.43%to 82.29%,while the predictability ranged from 88.88%to 93.08%in the mandible.Conclusion:(1)The arches were expanded during molar distaliza-tion with clear aligners;(2)The predictability ranged from 80.43%to 93.08%.It can be considered that the actual width change is close to the target change.
10.Correlation analyses between the ultrasound contrast feature and HER-2 expression,and between the ultrasound elastography feature and that in breast cancer
Shiyao LI ; Wei WANG ; Xiantan CAO ; Lei CHEN ; Chenjie LI ; Jun ZHANG
China Medical Equipment 2024;21(5):69-73
Objective:To analyze the correlations between the ultrasound contrast features and the expression of human epidermal growth factor receptor 2(HER-2)of molecular biological indicators of breast cancer,and between ultrasound elastography features and that.Methods:A total of 63 patients with invasive breast cancer who admitted to The Affiliated Suzhou Hospital of Nanjing Medical University and The First Affiliated Hospital of Jiamusi University from February 2019 to June 2022 were selected as the study subjects.The HER-2 positive expression of molecular biological indicator of breast cancer was measured by immunohistochemistry.According to the immunohistochemical results,the patients were divided into positive group(22 cases)and negative group(41 cases).All patients underwent examinations of ultrasound contrast and ultrasound elastography.The differences of the features of ultrasound contrast and ultrasound elastography between the two groups were analyzed and compared.The influencing factors of HER-2 positive expression were analyzed by binary logistic regression,and the receiver operating curve(ROC)was established to assess respectively the values of single ultrasound contrast,single ultrasound elastography and the combination of them in predicting HER-2 positive expression.Results:There was significant differences in the features of ultrasound elastography between the two groups.The ratios of the irregular shape and burr at the edge of the imaging features of the patients with HER-2 positive expression were significantly higher than those of the patients with HER-2 negative expression[(86.4%vs.58.5%)and(77.3%vs.51.2%)],and the differences were statistically significant(x2=5.117,4.060,P<0.05),respectively.The difference of the features of ultrasound contrast between two groups was significant.The ratios of nourishing vessels,and the lesion enlargement≥3 cm after angiography in patients with HER-2 positive expression were significantly higher than those in the patients with HER-2 negative expression[(77.3%vs.41.5%)and(81.8%vs.39.0%)],the differences were statistically significant(x2=7.390,10.554,P<0.05),respectively.The features(shape,edge,nourishing vessels and lesion enlargement after contrast)of ultrasound contrast and ultrasound elastography were used respectively as independent variables,and the HER-2 positive expression was used as dependent variables.The logistic regression analysis showed that regular shape,smooth edge,without nourishing vessels and enlarged lesion<3 cm after angiography were protective factors for HER-2 positive expression of patients with breast cancer(OR=0.185,0.199,0.070,0.186,P<0.05),respectively.The areas under curve(AUC)values of the ROC curve of imaging features(shape,edge,nourishing vessels,and lesion enlargement after angiography)of ultrasound contrast and ultrasound elastography were respectively 0.630,0.639,0.679 and 0.714 in single predicting HER-2 positive expression of patients with breast cancer,and that of the combination of them was 0.874 in prediction.Conclusion:In features of ultrasound contrast and ultrasound elastography,the shape,edge,nourishing vessels and the enlargement lesion after contrast were the influencing factors of HER-2 positive expression in patients with breast cancer.The combined assessment of ultrasound contrast and ultrasound elastography before surgery has certain clinical reference value in predicting HER-2 expression.

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